Summary
The FDA issued a Class II for HAND PACK-Procedure Kit Catalog Number: WEHD16B by American Contract Systems Inc. Reason: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as .
Details
Source
Device Recall
External ID
Z-2310-2024
Action Date
2024-07-17
Status
Ongoing
Category
device
Product Description
HAND PACK-Procedure Kit Catalog Number: WEHD16B
Lot/Code Info: UDI-DI: 00191072188632 LOT#"s: 662231 983241 934241
Quantity Affected: 135 units
Reason for Recall
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-15
Company
Tiffin, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 188 device recalls issued in the same week, part of 403 device-related FDA actions this month.
American Contract Systems Inc has 188 FDA actions in our database, including 188 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (American Contract Systems Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Contract Systems Inc have FDA actions?
American Contract Systems Inc has 188 FDA actions in our database, including 188 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2310-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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